BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM MRI

    MDR report key: 3992969 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01931
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 17, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, AND RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) ONLY LASTED THREE AND A HALF YEARS AND EARLY BATTERY DEPLETION WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466956 ENRHYTHM MRI PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EMDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization| R 5086MRI-52 LEA, 5086MRI-58 LEAD